恩替卡韦治疗慢性乙型肝炎的临床研究

目的评价恩替卡韦治疗慢性乙型肝炎(CHB)的疗效和安全性。方法72例CHB患者随机分配到治疗组和对照组,治疗组(30例)予恩替卡韦0.5mg/d;对照组(42例)予拉米夫定100mg/d疗程均48周,基础治疗相似。结果治疗组和对照组在治疗24周、48周时:血清HBV-DNA水平比基线值(log10copies/ml)平均下降分别为5.48、6.87和2.84、5.38;病毒应答率分别为53%、67%和21%、43%。均P<0.001,两组均有显著差异。ALT复常率分别为67%、77%和60%、67%,血清HBeAg阴转率、HBsAg消失率、不良事件发生率,均P>0.05,差异无统计学意义。无严重不良反应发生。结论恩替卡韦治疗慢性乙型肝炎,可在病毒学及生物化学方面取得显著疗效,且安全性良好,无耐药发生。

Study of Entecavir in treating chronic hepatitis B Patients

Objective To investigate the efficacy and safety of Entecavir in the treatment of chronic hepatitis B.Method Seventy-two patients with chronic hepatitis B were assigned to Entecovir(experimental) group(n=30) and LAM(control) group(n=42) randomly.Each patient in the experimental group received 0.5mg every day.Each patient in the control group received 100mg every day.All the patients were treated for 48 weeks.After 24 and 48-weeks of treatment,serum HBV DNA levels were measured and liver function tests.The HBV serology and safety assessments were also conducted.Results The mean reduction of HBV DNA from baseline at 24 and 48 weeks was significantly in the Entecovir group compared with that in the LAM group(-5.48,-6.87log10copier/ml and-2.84,-5.34log10 copies/ml,P<0.001).In the Entecavir group,the ratio of virological response and ALT normalization at 24 and 48-weeks were higher than those in the LAM group.There was no significant difference between the two groups in the portion of HBeAg reduction,HBsAg seroconversion and incidence of adverse events.There was no severe advere event in this trial.Conclusion Entecavir is effective and safe for the treatment of chronic hepatitis B patients.